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Oxiracetam freeze-drying preparation for injection and preparation method thereof

A technology for freeze-dried preparations and injections, which is applied in the field of freeze-dried preparations and preparations of oxiracetam for injection, and can solve the problem of not revealing whether the final product state exists in a crystalline form or an amorphous form, and it is impossible to know the stability and excellent quality. Inferior clinical efficacy, not involving the existing form of freeze-dried powder solids, etc., to achieve the effects of green production process, stable properties, and shortened production cycle

Active Publication Date: 2015-06-17
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In the existing lyophilized preparations of oxiracetam disclosed, although the problem of the degradation of oxiracetam in water during the preparation process has been noticed, the lyophilized preparations prepared by the generally adopted process have high water content and relatively high related substances. , the purity is low, and the quality is not stable enough; in addition, it does not involve the solid form of the freeze-dried powder, that is, it does not reveal whether the final product state after the freeze-drying of the preparation is in a crystalline form or an amorphous form, so that we have no way of knowing this. The stability, quality, and clinical efficacy of a solid form

Method used

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  • Oxiracetam freeze-drying preparation for injection and preparation method thereof
  • Oxiracetam freeze-drying preparation for injection and preparation method thereof
  • Oxiracetam freeze-drying preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1 Preparation of oxiracetam freeze-dried preparation of the present invention

[0048]

[0049] Preparation method: Take 2400ml of water for injection, adjust the temperature to 60°C, add the prescribed amount of oxiracetam, sorbitol, and mannitol, stir for 30 minutes (rotation speed is 40Hz), cool down to 25°C, add 1.2g of medicinal charcoal, Stir and adsorb for 15 minutes, decarbonize and filter, adjust the pH value of the filtrate to 5.4 with 5% NaOH, add water for injection to 3000ml, fine filter with a 0.22μm microporous membrane, take the filtrate, fill it in a vial after passing the test, and transfer Freeze-dry in a freeze dryer, seal the rubber stopper, press the aluminum cover, and pack.

[0050] Wherein, the step of freeze-drying is:

[0051] (1) Pre-freezing: the temperature of the plate layer is dropped from room temperature to -15°C for 1 hour and kept for 6 hours; continue to drop to -30°C for 23 minutes and kept for 2.5 hours;

[0052] (2...

Embodiment 2

[0055] Embodiment 2 Preparation of oxiracetam freeze-dried preparation of the present invention

[0056]

[0057]

[0058] Preparation method: Take 2400ml of water for injection, adjust the temperature to 65°C, add the prescribed amount of oxiracetam, sorbitol, and mannitol, stir for 35 minutes (rotation speed: 40Hz), cool down to 30°C, add 2.4g of medicinal charcoal, Stir and adsorb for 20 minutes, decarbonize and filter, adjust the pH value of the filtrate to 5.0 with 5% NaOH, add water for injection to 3000ml, fine filter with a 0.22μm microporous membrane, take the filtrate, fill it in a vial after passing the test, and transfer To freeze-drying machine for freeze-drying (the freeze-drying steps are the same as in Example 1), sealing rubber stoppers, pressing aluminum caps, and packaging.

Embodiment 3

[0059] Embodiment 3 Preparation of oxiracetam freeze-dried preparation of the present invention

[0060]

[0061] Preparation method: Take 2400ml of water for injection, adjust it to 55°C, add the prescribed amount of oxiracetam, sorbitol, mannitol and sodium hydroxide, stir for 40 minutes (speed 40Hz), cool down to 27°C, add 0.6g medicinal Charcoal, stir and adsorb for 25 minutes, decarbonize and filter, adjust the pH value of the filtrate to 5.5 with 5% NaOH, add water for injection to 3000ml, fine filter with a 0.22μm microporous membrane, take the filtrate, and fill it in a vial after passing the test , moved to a lyophilizer for lyophilization (the lyophilization steps are the same as in Example 1), sealed with rubber stoppers, pressed aluminum caps, and packaged.

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Abstract

The invention relates to an oxiracetam freeze-drying preparation for injection and a preparation method thereof, belonging to the technical field of medicines. The freeze-drying preparation is a crystal form compound formed by oxiracetam, D-sorbitol and mannitol in a weight ratio of 1: (0.2-0.25): (0.05-0.1). The oxiracetam freeze-drying preparation has the beneficial effects that the production cycle is shortened by about 20 hours, the rate of finished products is increased by above 99%, the phenomena such as the upward shifting and the eruption of the product are avoided, medicine molecules are constrained in crystal lattices, the water content is extremely low and can be controlled below 0.1%, the preparation is difficult to degrade and has relatively good stability, the period of validity is up to 36 months, the impurity content is greatly reduced, the single maximum impurity is less than 0.1%, and the total impurities are less than 0.5%; no organic solvents are involved in the production process, the energy consumption and the cost are substantially reduced, and the technology has environmentally-friendly effect and is suitable for large-scale industrialization production. Compared with the prior art, the oxiracetam freeze-drying preparation provided by the invention has obviously improved curative effect and is suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to the technical field of pharmaceutical preparations. The invention relates to a freeze-dried preparation of oxiracetam for injection and a preparation method thereof. Background technique [0002] Oxiracetam, whose chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, was first developed and synthesized by the Italian ISF S.P.A company in 1974. It was first listed in Italy in 1987 and is currently sold in China and Italy. , South Korea, Japan and other countries have been widely used in clinical practice. Its chemical structure is shown in formula 1: [0003] [0004] Oxiracetam is a nootropic drug. Research results show that Oxiracetam can promote the synthesis of phosphorylcholine and phosphorylethanolamine, promote brain metabolism, and stimulate the specific central nervous system through the blood-brain barrier. It has an obvious recovery effect on the neurological f...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4015A61K47/10A61P25/28
Inventor 孙鹏王金戌张育高志峰王晨光孙成勇张文静王丽丽
Owner CSPC OUYI PHARM CO LTD
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